Effects of rTMS Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia

Not Applicable

Completed

• Conditions: Aphasia; Stroke

• Registration Number: NCT02591719
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

The aim of this study is to assess the safety and clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.

Detailed Description

Most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.

In the present randomized controlled trial, investigators will perform fNIRS prior to rTMS treatment to select the stimulation method. Stimulation site (perilesional or contralesional) and frequency (excitatory high or inhibitory low) will be determined by activation pattern from the fNIRS with language task in individual patients.

The patient who shows a dominant neural activity at perilesional Broca's area on fNIRS scanning will be randomly allocated into two groups: high frequency stimulation group and sham stimulation group. If a patient shows a dominant neural activity at contralesional homologs of Broca's area on fNIRS scanning, the patient will be allocated to a low frequency stimulation group.

Study Timeline

• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Study Start: 2015-11-01
• Primary Completion: 2023-10-20
• Study Completion: 2023-10-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 18-80 yrs old
• Right-handed
• Radiologically confirmed left hemisphere stroke within 6 months
• Fluent in Korean
• First ever stroke
• Non-fluent (motor-dominant) aphasia
• Written informed consent

Exclusion Criteria

• Previous medical histories of stroke, cerebral vascular operation,
• Seizure
• Patients with traumatic brain injury
• Unable to perform the language task
• Severe cognitive impairment (MMSE less than 16)
• Skin lesion in the stimulation site of scalp
• Metal implants in the body (cardiac pacemaker or aneurysm clip)
• Pregnancy, breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BNT (Boston Naming Test)	up to 2 weeks	speech evaluation tool for measuring the confrontational word retrieval function

Secondary Outcome Measures

Name	Time	Method
LI (Laterality Index; From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemispheric HbO (oxyhemoglobin) or total Hb values, respectively)	up to 6 weeks	Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'
BNT (Boston Naming Test)	4 weeks	speech evaluation tool for measuring the confrontational word retrieval function
WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)	up to 6 weeks	Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of